A Smart Breath Analysis System for Non-Invasive Detection of Urease Activity in Helicobacter pylori Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
This research evaluates a novel smart breath analyzer designed to detect Helicobacter pylori infection by measuring urease activity in exhaled breath. The study will be conducted at Saveetha Medical College on 30 adults with gastrointestinal symptoms suggestive of H. pylori. Participants will perform the breath test after ingesting a urea solution, and results will be compared with standard diagnostic methods. The main objective is to determine the diagnostic accuracy (sensitivity and specificity) of the device. The study also assesses patient comfort, usability, and time to obtain results. If successful, the device could provide a rapid, non-invasive, and cost-effective alternative for diagnosing H. pylori.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Individuals aged 18 years and above.
- •Patients presenting with gastrointestinal symptoms suggestive of Helicobacter pylori infection (e.g., upper abdominal pain, bloating, nausea).
- •Patients who are willing and able to provide informed consent.
- •Participants willing to undergo both the smart breath analyzer test and standard diagnostic procedures for H.
排除标准
- •Patients who have taken antibiotics, proton pump inhibitors (PPIs), or bismuth compounds within the last 4 weeks.
- •History of gastrectomy or major gastrointestinal surgery.
- •Pregnant or breastfeeding women.
- •Patients with severe respiratory conditions (e.g., COPD) that may interfere with breath sampling.
- •Individuals with known allergies to the urea test substrate.
- •Cognitively impaired individuals unable to give informed consent.
研究者
GUNDETI THARUN REDDY
Saveetha medical college and hospital